The process of drug discovery and development is a hugely expensive one, which makes protecting that investment by efficiently managing the life-cycle of pharmaceutical licences, ever more essential.
Samarind RMS is a fit-for-purpose regulatory submissions tracking database application that has been designed from the outset as a user-friendly and time-efficient toolset for pharmaceutical industry professionals who deal with regulatory affairs.
As an award winning software house, we understand that it's all about the end-user, which is why we've worked in conjunction with experienced professionals operating within the pharmaceutical regulatory arena to ensure that the latest version of Samarind RMS continues to accomplish their key regulatory tasks:
- 'At a glance' visibility of all the products in your portfolio and the numbers and types of licences and variations pending and approved
- Product launch planning and tracking, to enable you to maximise the earnings potential of your new licences
- Comprehensive tracking of RMS and CMS submissions placed via the MRP or DCP and centralised procedures (CP), to help ensure everything happens according to plan
- Automated tools to simplify the management of parallel submissions, variations and manufacturer information, easing the administrative burden of keeping related information consistent and up to date
- A secure central repository of all your product licence documentation, from SmPCs and PILs to PSURs and business contracts, so that everyone knows where to find the most up-to-date version of these key documents
- A sophisticated role-based security system allows read-only access as well as the ability to control read-write access to different areas of the system
- The built-in Electronic Document Management System (EDMS) with template facilities and version control ensures that issued documents cannot be changed and keeps the history of all previous versions of a document
- Integrated eCTD publishing and viewing tools allow you to create your electronic dossiers in the correct XML format as defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the various regional authorities
- Automatic collation of EudraVigilance MPD data for transmission to the EMEA, to help you meet your vital pharmacovigilance obligations.
Samarind RMS is particularly suitable for generics companies, for whom speedy and efficient management of the licensing process is particularly important. Adopting a licence that has come off patent means 'speed to market' is absolutely critical; so it's vitally important to efficiently maintain pharmaceutical licences.
Samarind is continuously developing its regulatory affairs software to meet market requirements and support for the registration of medical devices is being added to the system.
For more details about using Samarind RMS within your business, please contact us.
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